Sr. Technical Writer

Confidential; North Carolina; On-site; USD 95,000 - 150,000; Full time

Job summary

Confidential in North Carolina seeks a QC Senior Technical Writer to author, review, and manage QC documents in a regulated cGMP environment. You will ensure lab reports, SOPs, and investigations comply with FDA regulations, GDP, and audit readiness, while supporting multiple programs.

Responsibilities include authoring SOPs, data verification, CAPA support, and cross-functional collaboration with QA/QC and analytical teams.

Qualifications

• Bachelor’s degree required with extensive cGMP experience.
• Experience writing SOPs, reports, and investigation documentation.
• Deep understanding of FDA 21 CFR Parts 210/211 and data integrity.

Responsibilities

• Author, edit, and maintain QC SOPs, test methods, specs, and protocols.
• Interpret QC data from tests (HPLC, ELISA, Microbiology) to generate compliant reports.
• Write and support investigations, CAPAs, deviations, and OOS documentation.
• Manage document lifecycle and version control using eQMS.
• Collaborate with QA/QC and analytical scientists to standardize docs.
• Ensure all docs meet cGMP, ICH, and regulatory standards.
• Support client visits, audits, and regulatory inspections.
• Ensure areas are cGMP compliant and audit-ready.
• Able to support 24/7 manufacturing.

Skills

Quality Compliance

Regulatory Knowledge

Leadership

Documentation Excellence

Data Interpretation

Audits

Education

Bachelor’s Degree in Chemistry, Biochemistry, Microbiology or related field with 10+ years of experience

Master of Science in related discipline with 5+ years of experience

Ph.D. in Science with 3+ years of experience

Job description

The QC Senior Technical Writer authors, reviews, and manages Quality Control documents. This role collaborates with subject matter experts to ensure lab reports, standard operating procedures (SOPs), and investigations strictly adhere to cGMP, GDP, and FDA regulations, directly supporting audit readiness and product compliance. They play a major role in the site operations while remaining adaptable to the changing needs for new clients and programs and is accountable for the sustained and ever-improving quality mindset as well as the consistent adherence to current good manufacturing practices (cGMP) throughout the site.

Job Description

What You'll Do:

• Document Authoring & Revision: Author, edit, and maintain high-quality QC Standard Operating Procedures (SOPs), analytical test methods, specifications, and technical protocols.
• Data Verification: Interpret intricate scientific and technical data from QC testing (e.g., HPLC, ELISA, Microbiology) to generate accurate, compliant technical reports and trending summaries.
• Investigations & CAPAs: Write, review, and support root-cause analyses, Out of Specification (OOS) investigations, deviations, and CAPA (Corrective and Preventive Actions) documentation.
• Document Management: Manage document lifecycle and version control using electronic Quality Management Systems (eQMS).
• Cross-Functional Collaboration: Partner with Quality Assurance (QA), Quality Control (QC), and analytical scientists to streamline technical writing workflows and standardize documentation formats.
• Compliance & Audit Readiness: Ensure all documentation complies with cGMP, ICH guidelines, and global regulatory submission standards.
• Supports strategic decision-making; prioritizes deliverables to meet site and compliance objectives
• Supports and participates in client visits, audits, and regulatory agency inspections
• Assures all areas of responsibility conform to cGMP and other appropriate regulatory
• Interacts and meets regularly with cross-functional leaders on matters concerning their functional areas, groups or clients
• Assures that all areas of responsibility are cGMP compliant and audit-ready
• Performs all other duties, as assigned
• Bachelor’s Degree in Chemistry, Biochemistry, Microbiology or related field with 10+ years of experience OR
• Master of Science (M.Sc.) in a related discipline with 5+ years of experience OR
• Ph.D. in Science with 3+ years of experience
• Technical and regulatory understanding and experience of biologics, gene, and/or cell therapy QC with an understanding of control strategy
• Experience leading client site visits, audits, and regulatory inspections
• Experience managing in a matrix organization and collaborating at a global level
• Experience working in a regulated GMP environment

Preferred Qualifications:

• 10+ years of experience working as a Technical Writer in a regulated GMP environment

Knowledge, Skills, or Abilities:

• Strong orientation for quality, compliance, business ethics and customer service.
• Strong leadership, collaboration, team building, program management and organizational skills
• Exceptional verbal and interpersonal skills required to effectively interview and collaborate with various SMEs.
• Ability to manage multiple document revisions and shifting deadlines simultaneously
• High level of integrity and a drive for continuous improvement
• Excellent judgment and creative problem-solving skills, including negotiation and conflict resolution
• Excellent interpersonal, organizational, and written and oral communication skills
• Mastery knowledge of document management and lifecycle, and quality systems and their interconnections
• Mastery of GMP, regulations, and inspection/audit readiness
• Deep understanding of cGMP, FDA 21 CFR Parts 210/211, and data integrity standards.
• Must be flexible to support 24/7 manufacturing facility